MEMORANDUM AMICI CURIAE OF PUBLIC CITIZEN, NATIONAL CENTER FOR TOBACCO-FREE KIDS, AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY, AMERICAN COLLEGE OF PREVENTATIVE MEDICINE, AMERICAN HEART ASSOCIATION, AMERICAN LUNG ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, AMERICAN MEDICAL WOMEN'S ASSOCIATION, AMERICAN PUBLIC HEALTH ASSOCIATION, AMERICAN SOCIETY OF ADDICTION MEDICINE, THE HMO GROUP, NATIONAL ASSOCIATION OF AFRICAN AMERICANS FOR POSITIVE IMAGERY, NATIONAL ASSOCIATION OF ELEMENTARY SCHOOL PRINCIPALS, NATIONAL ASSOCIATION OF SECONDARY SCHOOL PRINCIPALS, AND NATIONAL PTA IN OPPOSITION TO PLAINTIFFS' MOTION FOR SUMMARY JUDGEMENT

NATURE OF THE MATTER BEFORE THE COURT

This brief is submitted in support of the final rule issued by defendant Food and Drug Administration ("FDA") to restrict the sale and promotion of tobacco products to minors. 61 Fed. Reg. 44396 (1996). Amici are 16 organizations with long-standing interests in public health, especially in the health of children and in protecting children from the harms caused by tobacco products. The groups are more fully described in an appendix to this brief.

STATEMENT OF MATERIAL FACTS

Tobacco use is the single most preventable cause of premature death and disease in the United States. Millions of Americans are addicted to tobacco products; more than 400,000 people die each year of diseases attributable to tobacco use; nearly one in five eighth graders and one in three twelfth graders smoke cigarettes; and tobacco use that results from addiction to the nicotine in cigarettes causes more Americans deaths each year than AIDS, alcohol, car accidents, murders, suicides, and fires combined. 60 Fed. Reg. 41314, 41314-15 (1995). Tobacco product manufacturers carefully engineer their products to deliver doses of nicotine to consumers, to create and to satisfy nicotine addiction. 61 Fed. Reg. 44915-94.

Amici hereby incorporate by reference the Statement of Material Facts contained in the brief of defendants FDA and Commissioner David Kessler.

QUESTIONS PRESENTED

1. Has Congress precluded the FDA from regulating tobacco products?

2. Does the Food, Drug, and Cosmetic Act give the FDA jurisdiction over tobacco products?

3. Do any of the FDA's restrictions on the advertising and promotion of tobacco products to minors violate the First Amendment to the United States Constitution?

SUMMARY OF ARGUMENT

The challenges to the FDA's rule fall into two general categories: those contesting the authority of the FDA to regulate tobacco products at all, and those contesting the validity of specific regulations under the First Amendment. Plaintiffs' jurisdictional challenge raises two separate claims. In its First Brief, the industry contends that, even if tobacco products meet the definition of drug and drug-delivery systems under the Food, Drug, and Cosmetic Act ("FDCA"), Congress has affirmatively forbidden the FDA from regulating tobacco products. This argument is based on laws in which Congress has assigned certain duties regarding tobacco to other federal agencies, and on instances in which Congress has considered proposals that would have explicitly recognized the FDA's authority over tobacco products. The industry claims that, through such action and inaction, Congress effectively has precluded the FDA from regulating tobacco products, even if the FDCA would otherwise confer jurisdiction over tobacco products on the Agency.

Plaintiffs' argument is fundamentally flawed because it equates congressional inaction with a congressional prohibition enacted into law. Congress can remove or withhold agency power only in the same way that Congress grants it: by passing a law, which it has not done here. Indeed, in various statutes, including one part of the FDCA, Congress has expressly precluded an agency from regulating tobacco. Congress has never done so with regard to the FDA's authority over drugs and medical devices. In fact, even the industry admits that no such prohibition exists, for it acknowledges that the FDA may regulate tobacco products that are marketed with claims of pharmacological effect, such as to help with weight loss. Yet, if the industry's argument were correct, the FDA would be precluded from regulating in those instances as well.

In their Second Brief, plaintiffs question whether the definitions of "drug" and "device" in the FDCA encompass tobacco products, which contain nicotine, a substance that everyone agrees has significant pharmacological effects. The industry principally argues that the statutory definitions cover only products explicitly promoted for therapeutic purposes. This claim overlooks the fact that the applicable definitions are written in the alternative, and the parts of the definitions on which the FDA relies are not tied to health claims. Rather, under the FDCA, a product is a drug or device if it is "intended to affect the structure or any function of the body." Because actors are presumed to intend the foreseeable consequences of their conduct, because the addiction and disease that result from use of tobacco products is well-established, and because voluminous documentation in the administrative record establishes the industry's knowing exploitation of the effects of nicotine, the nicotine in tobacco products easily falls within the statutory definition of "drug."

Moreover, the FDA has properly determined that cigarettes and smokeless tobacco products are "pre-filled drug-delivery systems," a combination product consisting of (1) a drug and (2) a device used to deliver the drug to the body. The administrative record reveals that the industry purposefully engineers its products to deliver the drug nicotine to the body. Indeed, numerous industry documents openly state that their products' purpose is to deliver nicotine. And because the FDA's existing procedure allows the FDA to regulate such combination products as either drugs or devices, the Agency acted properly in deciding to apply the device authorities to tobacco products.

In their Third Brief, plaintiffs charge that the advertising restrictions adopted by the FDA violate the First Amendment. In making their argument, plaintiffs obscure the most important aspect of these restrictions: They are aimed at reducing the demand for tobacco products by people under the age of 18, who are forbidden by both federal and state law from purchasing such products. Surely, even these plaintiffs would not contend that banning tobacco ads in the Weekly Reader, prohibiting tobacco ads on billboards directly across the street from entrances to schools and playgrounds, or forbidding ads portraying characters such as Big Bird or Barney would run afoul of the First Amendment, yet that is the impact of their argument.

In addition, the Agency has carefully tailored its restrictions to apply only where tobacco advertisements would be seen by substantial numbers of minors and only to the types of ads that have the greatest impact on children. Such regulations inevitably require line drawing. Here, where the Agency has cited substantial evidence in support of its rule and has provided all interested parties an opportunity to comment and provide additional evidence, the FDA is entitled to reasonable latitude, particularly where no blanket ban is involved and the industry is left numerous alternative means of communication. Thus, for example, limiting advertisements that young people are likely to see to a black and white, text-only format required the FDA to draw a bright line, and it drew that line at publications with 15 percent minor readership or 2,000,000 minor readers. The industry did not suggest any alternative lines that would serve the FDA's goals in a less intrusive way. As to the restriction on billboard ads, where the agency drew the line at 1000 feet from a school or playground, the industry never mentions that its own voluntary code draws a similar line at 500 feet and never offers any evidence, or even argument, as to why the Constitution requires the FDA to honor the industry's line rather than its own. Given the nature of the harm that can befall children who become addicted to tobacco products, the evidence relied on by the Agency, and the vital need to cut down on demand for those products among minors, the FDA was well within the boundaries set by the First Amendment in restricting advertising and promotion with the greatest impact on minors, while continuing to permit the industry to use any approach it chooses when its efforts are directed at adults.

ARGUMENT

I. CONGRESS HAS NOT PRECLUDED THE FDA FROM REGULATING TOBACCO PRODUCTS.

The stated question in plaintiffs' First Brief (at 2) is whether Congress "withheld from the FDA the authority to regulate" tobacco products. The brief actually argues, however, that Congress has forbidden the FDA from regulating tobacco products. Plaintiffs point both to statutes specifically authorizing other agencies to regulate some aspect of the tobacco business and to the fact that Congress has not enacted laws that explicitly tell the FDA to regulate tobacco. That history arguably bears on the proper interpretation of the statute relied on by the FDA that Congress did enact into law, discussed infra at Part II., but the argument that this case can be decided by discerning the meaning of congressional inaction is without merit. If tobacco products satisfy the FDCA definitions of drug and drug-delivery devices, plaintiffs' argument fails. If they do not, the argument is irrelevant.

Under our Constitution, Congress may make laws that affect the conduct of others only in one manner: by the passage of a bill approved by both Houses, which the President signs or which he vetoes but two-thirds of each House vote to override. There is no other means by which Congress may constitutionally act. INS v. Chadha, 462 U.S. 919, 951, 103 S.Ct. 2764, 77 L.Ed.2d 317 (1983) ("[T]he legislative power of the Federal Government [must] be exercised in accord with a single, finely wrought and exhaustively considered, procedure"). Accord Central Bank v. First Interstate Bank, __ U.S. __, 114 S.Ct. 1439, 1453, 128 L.Ed.2d 119 (1994) (cautioning against use of legislative inaction to aid in statutory interpretation). Since, as Chadha held, Congress may not, even in a statute, delegate the power to make law in any other way, congressional inaction here cannot deny to the FDA the power to regulate tobacco products if the FDA otherwise has such power. Cf. Train v. City of New York, 420 U.S. 35, 45, 95 S.Ct. 839, 43 L.Ed.2d 1 (1975) ("Legislative intention, without more, is not legislation.").

Plaintiffs do not cite to any express provision that precludes the FDA from regulating tobacco products as either drugs or medical devices because none exists. This absence is particularly striking since when Congress wants to preclude an agency from exercising authority over tobacco products, it does so explicitly. For example, as part of the Dietary Supplement Amendments of 1994, Congress defined "dietary supplement" to exclude "tobacco" products. 21 U.S.C. 321(ff). That definition is in the same statute, the FDCA, as the definitions of drug and device on which the FDA relies. See 21 U.S.C. 321(g) & (h). Thus, Congress could have precluded FDA jurisdiction here if it had wanted to do so. Also in Title 21, Congress defined "controlled substance" by expressly excluding "tobacco." 21 U.S.C. 802(6). And elsewhere, Congress expressly prohibited other agencies from regulating tobacco products under other broad regulatory regimes: "chemical substance" under the Toxic Substances Control Act excludes "tobacco or any tobacco product," 15 U.S.C. 2602 (2)(B)(iii); "hazardous substance" under the Hazardous Substances Act, 15 U.S.C. 1261(f)(2), excludes "tobacco or tobacco products." (See Footnote 1) Similar exclusions are also contained in the Consumer Product Safety Act (15 U.S.C. 2052(a)(1)(B)) and the Fair Packaging and Labeling Act (15 U.S.C. 1459(a)(1)). Because Congress has not enacted such an exclusion here, the Court should not do so in its stead.

Moreover, plaintiffs ignore the internal inconsistency of their argument. They admit, in their question presented, that the FDA has at least some jurisdiction over tobacco products. Thus, they do not claim that the FDA acted unlawfully in asserting jurisdiction over cigarettes sold with claims of health benefits. See United States v. 46 Cartons, More or Less, Containing Fairfax Cigarettes, 113 F. Supp. 336 (D.N.J. 1953); United States v. 354 Bulk Cartons, 178 F. Supp. 847 (D.N.J. 1959). Rather, they suggest that Congress "approved" those cases in the same way that it allegedly disapproved the FDA's assertion of jurisdiction here--by doing nothing, First Brief 9 n.10; and they conclude that FDA authority has been "withheld" only over tobacco products "as customarily marketed"--a phrase that appears nowhere in the statute or its history, although Congress has written that type of restriction into other statutes. See 15 U.S.C. 1459(a) ("consumer commodity" is product "customarily produced or distributed for sale through retail sales agencies"). Yet if Congress actually forbade the FDA from regulating tobacco products, such a ban would include cases where health claims are asserted because there is nothing in the FDCA that makes the FDA's jurisdiction over tobacco products turn on whether the products are "customarily marketed."

Plaintiffs offer a variation on their theme by arguing that Congress has comprehensively regulated tobacco products in a way that leaves no room for the FDA. A number of the statutes they cite--such as those imposing taxes on tobacco or those setting agricultural quotas for tobacco--are so far afield as not to be worthy of a reply. Even the most closely related provision--the Federal Cigarette Labeling and Advertising Act of 1965, as amended ("FCLAA")--does not support the industry's claim that Congress has affirmatively deprived the FDA of authority to regulate tobacco products.

In essence, plaintiffs argue that the FCLAA regulates tobacco products so comprehensively that it preempts the entire field of tobacco regulation. The industry made a similar argument in opposing state tort law claims for money damages, which the Supreme Court unanimously rejected, see Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), although the Court held that some specific damages claims were preempted by 15 U.S.C. 1334(b), which applies only to state regulatory requirements. The FCLAA's federal preemption provision, 15 U.S.C. 1334(a), restricts federal agencies only from mandating additional statements relating to smoking and health "on any cigarette package," which the FDA's rules do not require. Indeed, prior to the 1969 amendments to the statute, when a broader state preemptive provision applied to federal agencies, the D.C. Circuit in Banzhaf v. FCC, 405 F.2d 1082, 1088, 1090 (1968), narrowly construed it to extend only to requirements for affirmative statements related to smoking and health.

Although the declaration of policy contained in section 1 of the original 1965 FCLAA stated that Congress intended to enact a "comprehensive" program regarding the labeling and advertising of cigarettes, that statute was never a truly comprehensive cigarette regulatory law. Rather, it precludes federal agencies from acting only to the extent stated in 15 U.S.C. 1334(a). Even with the 1984 addition of statutory warnings for cigarette advertisements, Congress neither expanded the scope of preemption nor included many areas of potential regulation, the most obvious being sales and marketing to minors. Surely, the industry does not contend that state laws banning cigarette sales to minors, which predate the FCLAA, were somehow preempted by Congress in the FCLAA. Nor could industry contend that, if a public elementary school banned cigarette advertisements in its newspaper, or prohibited free samples or Joe Camel posters on its grounds, those measures would be preempted by section 1334(b) of the FCLAA. In fact, the Fourth Circuit recently rejected a preemption challenge to a Baltimore ordinance that contains an even broader ban on billboard tobacco advertising than the FDA rule. Penn Advertising v. Mayor & City Council of Baltimore, 63 F.3d 1318 (4th Cir. 1995). And the Supreme Court vacated and remanded that case solely on a First Amendment issue, although the petition for certiorari also raised a preemption question. See 116 S.Ct. 2574 (1996). Since the FCLAA does not even preempt all regulation of cigarette advertising, it clearly does not preempt the entire field of tobacco regulation.

For similar reasons, the preemption provision of the Comprehensive Smokeless Tobacco Health Education Act, 15 U.S.C. 4406(a), does not preempt the field of smokeless tobacco regulation. That provision bans federal and state laws requiring additional statements on packages and in advertisements beyond those mandated by Congress (but excludes billboards from its reach). It does not preempt any other federal, state, or local regulation. In regard to the few areas in the FDA's rule involving labeling on packages, the FDA correctly concluded that the Smokeless Tobacco Act does not preempt any of the regulations at issue. 61 Fed. Reg. 44396, 44544-45. With respect to the requirement that smokeless ads include the words "A Nicotine-Delivery Device for Persons 18 or Older" (21 C.F.R. 897.32(c)), the Agency does not consider the statement to "relate[] to smokeless tobacco and health." Rather, the statement identifies the legal classification of the product and who may lawfully purchase it. Accordingly, it is not preempted.

Plaintiffs also claim that the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992, 42 U.S.C. 300x-26 ("ADAMHA"), eliminated all FDA jurisdiction over tobacco. That claim is without merit. The ADAMHA is a modest effort to reduce underage tobacco use by strengthening state enforcement efforts of laws restricting youth access. The law is not mandatory, as any state may choose not to step up enforcement in return for foregoing federal funding for substance abuse programs. There are no federal sanctions for sales to minors. There are no provisions designed to reduce minors' demand for tobacco products. And, most significantly, there is no preemption provision of any kind. About all that can meaningfully be said about the ADAMHA is that it confirms the FDA's view that underage tobacco use is a serious problem and shows that Congress was willing to use federal tax dollars to enlist the states in the fight. Moreover, the broad preemption by implication theory espoused by plaintiffs here was rebuffed by the Supreme Court not only in Cipollone, but more recently in Medtronic, Inc. v. Lohr, __ U.S. __, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Moreover, accepting the logical reach of plaintiffs' argument would result in revocation of the FDA's long-standing jurisdiction over tobacco products for which health claims are made. The Court should reject this attempt to convert a narrow law designed to protect minors into one that would shield the tobacco industry.

Recognizing that no statute actually forbids the FDA from regulating tobacco, plaintiffs turn to congressional failures to enact positive authorizing legislation as a basis for denying the FDA the power to issue these regulations. However, "[c]ongressional inaction cannot amend a duly enacted statute." Patterson v. McLean Credit Union, 491 U.S. 164, 175 n.1, 109 S.Ct. 2363, 105 L.Ed.2d 132 (1989). Nor should congressional silence be construed as a rejection of the FDA's actions under its existing statutes. As Justice Scalia has admonished the courts:

[O]ne must ignore rudimentary principles of political science to draw any conclusions regarding [congressional] intent from the failure to enact legislation. The "complicated check on legislation," The Federalist No. 62, p. 378 (C. Rossiter ed. 1961), erected by our Constitution creates an inertia that makes it impossible to assert with any degree of assurance that congressional failure to act represents (1) approval of the status quo, as opposed to (2) inability to agree upon how to alter the status quo, (3) unawareness of the status quo, (4) indifference to the status quo, or even (5) political cowardice.

Johnson v. Transportation Agency, 480 U.S. 616, 671-72, 107 S.Ct. 1442, 94 L.Ed.2d 615 (1987) (Scalia, J., joined by Rehnquist, C.J., dissenting).

An example forcefully illustrates the inappropriateness of relying on congressional inaction to establish the meaning of duly enacted laws. After the FDA published its proposed rule, several Members of Congress from North Carolina and Kentucky introduced bills that would explicitly have forbidden the FDA from regulating tobacco products. See 61 Fed. Reg. 45259 (citing bills). Those bills were not enacted. Under plaintiffs' theory, such inaction would constitute a decision by Congress to allow the FDA to proceed. Or suppose that such a bill was passed by both Houses, but that the President vetoed it, and an override vote fell one vote short in one House. Under plaintiffs' approach, a court should construe that outcome as acceptance, or at least acquiescence, in the FDA's authority over tobacco products. Moreover, plaintiffs' approach to congressional inaction would mean that Congress is implicitly ratifying the FDA's final rule, and its jurisdiction, if it fails to overrule the rule pursuant to the 1996 amendments to the Administrative Procedure Act, under which the effective date of all major rules is delayed to allow Congress time to enact a joint resolution of disapproval to overrule the agency's rulemaking. 5 U.S.C. 800 et seq.

All of these attempts to use legislative silence are inappropriate. The only way to interpret what Congress meant in a statute is by examining that statute, with all of the proper tools of legislative interpretation, a task to which we now turn.

II. THE FDCA AUTHORIZES THE FDA TO REGULATE TOBACCO PRODUCTS.

In 1972, an R.J. Reynolds researcher wrote, "In a sense, the tobacco industry may be thought of as being a specialized, highly ritualized and stylized segment of the pharmaceutical industry." 61 Fed. Reg. 44867. That same year, a Philip Morris scientist wrote, "Think of the cigarette as a dispenser for a dose unit of nicotine." Id. 44856. In 1981, Brown & Williamson's parent corporation, BATCO, wrote "In a nutshell, our approach has been to regard nicotine as a drug." Id. 44888. Notwithstanding these frank admissions, plaintiffs argue that tobacco products are neither "drugs" nor "drug-delivery devices" under the FDCA. Their argument is based on the mistaken claim that only a company's public representations about a product's therapeutic effects can bring the product within the statutory definitions of drugs or devices. The FDCA definitions of drugs and devices, however, are not nearly so narrow.

Under the FDCA definitions, the nicotine in tobacco products is a drug because it is intended to have a pharmacological effect, and cigarettes and smokeless tobacco products are devices through which the drug nicotine is delivered to the body. Together, the drug and the device form a "drug-delivery system," a type of "combination product" that (1) contains a drug, as that term is defined by the FDCA, and (2) has the primary purpose of delivering or aiding in the delivery of the drug. The FDA may appropriately regulate such products under either the drug or the device authorities.

A. Nicotine In Tobacco Products Is A "Drug," Within The Meaning Of The FDCA.

The FDCA defines the term "drugs" as, among other things, "(B) articles intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals." 21 U.S.C. 321(g)(1). Thus, a product that has pharmacological effects on the body--bringing it within the lay definition of drug--falls within the statutory definition if it is intended either (1) to be used to treat or prevent disease or (2) to otherwise affect the body. See also United States v. An Article of Drug ... Bacto-Unidisk, 394 U.S. 784, 793, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969) (FDCA definition of "drug" is term of art that encompasses far more than strict medical definition).

The fact that nicotine has pharmacological effects on the human body is undisputed. Indeed, the FDA regulates other nicotine products, such as nicotine patches and nicotine chewing gum, and the tobacco industry has not challenged the FDA's assertion of jurisdiction over those products. In this case, the FDA's authority is based on the determination that nicotine in tobacco products is a drug within the meaning of subsection (C) because it is "intended to affect the structure or any function of the body." 61 Fed. Reg. 44403.

Under FDA regulations, the phrase "`intended uses' or words of similar import" refers to the "objective intent of the persons legally responsible for the labeling of drugs." 21 C.F.R. 201.128; see id. 801.4 (devices).

The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, . . . be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. . . .

Id. 201.128 (drugs); id. 801.4 (devices). Although plaintiffs contend that the FDA's interpretation of the term "intent" in connection with the regulations is "unprecedented," the regulations defining intent were issued in the 1950s. Id. 210.128, 801.4. See Second Brief 14. Insofar as amici are aware, they have never been challenged. Furthermore, the FDA's interpretation of "intent" is in keeping with centuries of Anglo-American law. See, e.g., Hadley v. Baxendale, 156 Eng. Rep. 145 (1854).

Consistent with 21 C.F.R. 201.128 and 801.4, the phrase "intended to affect" must also mean "objective" intent, that is, whether the effect was a deliberate or foreseeable consequence of the act. See 61 Fed. Reg. 44691 (citing cases and treatise). Here, the administrative record conclusively demonstrates not only that tobacco product manufacturers could reasonably foresee that their products would be used for the pharmacological effects of nicotine, but also that they purposefully engineer their products to exploit and promote those effects, including the effect of addiction. The record, which is based on numerous sources, shows that manufacturers manipulate the amount and delivery of nicotine in tobacco products and that nicotine levels are no longer a by-product of tar levels. The record also establishes that manufacturers consider their products nicotine-delivery systems and that they have done extensive studies of the effects of nicotine, including addictiveness. The record reflects a telling absence of any evidence that the industry perceives the nicotine in its products as having any function other than to create pharmacological effects on the human body.

1. Plaintiffs argue that the intent component of the subsection (C) definition of drugs can be satisfied only by industry statements making express claims regarding health (for example, weight loss, stress reduction, appetite suppression). Second Brief 7. Because manufacturers make no therapeutic claims for their products, plaintiffs argue that the FDA cannot regulate them. However, the statutory definition of drugs requires neither therapeutic uses nor specific therapeutic claims. Again, subsection (B) of the FDCA definition includes as drugs "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," that is, articles intended for therapeutic uses. For instance, if Marlboro cigarettes were marketed to treat nicotine withdrawal, the product would qualify as a "drug" under subsection (B). On the other hand, subsection (C) defines drugs to include "articles (other than food) intended to affect the structure or any function of the body." Both logic and basic rules of statutory construction dictate that subsection (C) must bring into the definition of drugs items for which no therapeutic use is presented and no therapeutic claims are made. Otherwise subsection (C) would be redundant of subsection (B) and, therefore, surplusage. See National Insulation Transp. Comm. v. ICC, 683 F.2d 533, 537 (D.C. Cir. 1982) (court must, if possible, give effect to every phrase of a statute so that no part is rendered superfluous); Symons v. Chrysler Corp. Loan Guarantee Bd., 670 F.2d 238, 242 (D.C. Cir. 1981) (rejecting interpretation that would render statutory phrase superfluous because statutes should be construed, if possible, to give effect to every word used by Congress). (See Footnote 2)

Accordingly, because under subsection (C) intent is not tied to therapeutic use, the FDA may regulate products marketed without such representations if the products are intended to be used for their pharmacological effects. See United States v. 789 Cases, More or Less, of Latex Surgeons' Gloves, 799 F. Supp. 1275, 1285 (D.P.R. 1992) ("All of the circumstances surrounding the promotion and sale of the product constitute the `intent.' It is not enough for the manufacturer to merely say that he or she did not `intend' to sell a particular product as a device."). Thus, for example, in 1987, the FDA determined that Advanced Tobacco Products' new product FAVOR, a cigarette-like device consisting of a plug impregnated with a nicotine solution inserted with a tube, corresponding in appearance to a conventional cigarette, was a new drug intended as an alternative nicotine-delivery system for cigarette smokers, to satisfy nicotine dependence and to create nicotine effects. (See Footnote 3)

2. Of course, the tobacco industry knows that nicotine affects the body and how it does so. The industry has conducted many, if not most, of the studies of nicotine's pharmacological effects. Even if it feigned ignorance, however, such knowledge would be imputed to it. It is a well-known fact that nicotine affects the structure or function of the body. "Nicotine's effects on the brain are the biological basis of nicotine addiction--an addiction that has been proven by a wealth of laboratory and epidemiological evidence and recognized by every major independent medical organization that has studied the question." 61 Fed. Reg. 44701; id. 44702-06. Applying the intent standard that is integrated into the FDCA's definition of "drugs," the manufacturers are charged as a matter of law with having foreseen the reasonable consequences of their actions. See Lee v. Lee County Bd. of Educ., 639 F.2d 1243, 1267 (5th Cir. 1981) (objective intent "presumes that a person intends the natural and foreseeable consequences of his voluntary actions"). And the reasonable consequence of the manufacturers' actions--carefully controlling the amount, form, and delivery of nicotine in their products--was and is to affect the structure and function of the bodies of consumers of tobacco products. Because the effect is so great--as many as 92 percent of smokers are addicted to nicotine, 61 Fed. Reg. 44730--any claim that such consequences are not foreseeable would not be credible. (See Footnote 4)

3. Notwithstanding foreseeability, the manufacturers' own documents reveal their actual intent to use their products as nicotine-delivery systems. For example, a Philip Morris report placed tobacco products in the category of "nicotine delivery devices," along with nicotine patches and nicotine gum. 61 Fed. Reg. 44866. An industry research conference in 1962 candidly discussed the drug effects of nicotine. Id. 44882-83 (Brown & Williamson). Reports of tobacco industry researchers in the 1970s and 1980s confirmed the physiological and psychological effects of nicotine. Id. 44868-73 (RJR), 44886-90 (Brown & Williamson). And industry documents show that tobacco companies, through their manufacturing processes, can and do control the amount, form, and delivery of nicotine in their products, with the pharmacological effects firmly in mind. Id. 44917-46 (cigarettes); id. 45108-24 (smokeless tobacco companies use product-design features to control nicotine delivery and to promote tolerance and addiction to nicotine); e.g., id. 44942 (addition of ammonia to increase delivery of nicotine); id. 44868 (memo from cigarette manufacturer referring to cigarette as "nicotine delivery system"). Manufacturers have the ability to remove nicotine from tobacco products entirely, as Philip Morris' "Next" brand cigarette demonstrated. See 60 Fed. Reg. 41779-83 (citing patents for methods to extract nicotine from tobacco). Manufacturers also have the ability to increase the amount of nicotine. See, e.g., 61 Fed. Reg. 44952-63. And they have the ability to control the amount and delivery of nicotine in their products. See, e.g., id. 44963-74 (cigarettes); id. 45110-14 (smokeless tobacco).

4. As support for their argument that "intent" can be manifest only by public claims of therapeutic effect, the industry relies on FDA statements made at congressional hearings and on the FDA's response to a 1977 petition to the FDA filed by Action on Smoking and Health ("ASH"), which urged the FDA to assert jurisdiction over cigarettes sold without therapeutic claims. Second Brief 7. Plaintiffs' reliance on the Agency's past statements is misplaced.

First, the FDA's response to the ASH petition explicitly recognized that the determination of intent was not dependent on manufacturers' public claims and that objective evidence, including evidence of consumer use, could outweigh the manufacturers' statements. Letter from FDA Commissioner Goyan to Banzhaf, Nov. 25, 1980, at 8-9 (citing National Nutritional Foods Ass'n v. FDA, 504 F.2d 761, 789 (2d Cir. 1974)). The FDA found, however, that the ASH petition lacked sufficient evidence on this point. Accordingly, until the FDA obtained additional evidence (for example, that as many as 92 percent of smokers are addicted and that manufacturers deliberately control the level and form of nicotine in their products to addict users, to keep users hooked, and to provide the physical effects of nicotine), the Agency's consideration of intent was controlled by the industry's promotional statements. The tobacco industry's avoidance of express health claims and its lies to Congress and the public about its knowledge of nicotine's addictiveness left the FDA with no recourse but to disclaim jurisdiction over tobacco products. Thus, even if the FDA agreed with the ASH assertions in 1977, it lacked the evidence on which its final rule is based. Now, the evidence before the FDA of manufacturers' extensive research into the pharmacological effects of nicotine and their manipulation of the amount and delivery of nicotine enables the Agency to regulate tobacco products as drugs. See generally 61 Fed. Reg. 44915-49; see also Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980) ("Nothing in this opinion should suggest that the [FDA] is irrevocably bound by any long-standing interpretation and representations thereof to the legislative branch" regarding its jurisdiction over tobacco products). Tellingly, plaintiffs fail to address the significance of manufacturers' manipulation of nicotine in their products and of the evidence acquired by the FDA in recent years on that topic.

Second, the prior FDA statements on which plaintiffs rely do not bear on whether the FDCA grants the FDA authority over tobacco products. Even if the Agency had previously interpreted the FDCA to assess intent solely by whether a manufacturer made express therapeutic claims, the Agency is free to reject prior interpretations of its organic statute. Chisholm v. FCC, 538 F.2d 349, 364 (D.C. Cir.) ("[A]n administrative agency is permitted to change its interpretation of a statute, especially where the prior interpretation is based on error, no matter how longstanding."), cert. denied, 429 U.S. 890 (1976); see also Rust v. Sullivan, 500 U.S. 173, 186, 111 S.Ct. 1759, 114 L.Ed.2d 233 (1991) (where an agency's interpretation of the statute represents a "break with prior interpretations," the courts will nonetheless grant it substantial deference) (citing Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837, 862, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984)); see id. at 184. The agency must "provide a reasoned explanation for its" change in position, Action on Smoking and Health, 655 F.2d at 242 n.10, but it is not required to "establish rules of conduct to last forever." Motor Vehicles Mfrs. Ass'n v. State Farm Mutual Ins. Co., 463 U.S. 29, 42, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983). See United States v. Southwestern Cable Co., 392 U.S. 157, 88 S.Ct. 1994, 20 L.Ed.2d 1001 (1968); accord Chisholm v. FCC, 538 F.2d at 364. And if the statutory language is ambiguous, an agency's regulations will be upheld as long as they are "based on a permissible construction of the statute." Chevron, 467 U.S. at 842-43. Here, the FDA's present interpretation is the most straightforward because nothing in the statutory language defining "drug" or the regulatory language defining "intent" limits determinations of intent to public statements. If it did, Prozac could be sold as an unregulated product as long as it were advertised without health claims, although its manufacturer knows it will have pharmacological effects and sells it for that reason, and although it would still be a "drug" when promoted as an anti-depressant.

The FDA's interpretation prevents drug manufacturers from side-stepping the regulatory process by misrepresenting their true objectives or by claiming that their subjective intent controls, even in the face of known pharmacological effects produced by ordinary use of the product. At the same time, the FDA's interpretation protects against FDA regulation of products, for example, model airplane glue, that can be used to affect the structure or function of the body but are neither engineered nor sold for that purpose, and are not used by the majority of consumers for that purpose. Accordingly, the FDA's action is based on "a plausible construction of the plain language of the statute and does not otherwise conflict with Congress' expressed intent." Rust v. Sullivan, 500 U.S. at 184. (See Footnote 5)

5. United States Tobacco Co., et al., argues that smokeless tobacco is "merely a processed plant." US Tob. Brief 15. To begin with, the fact of being a plant is not sufficient ground for evading FDA jurisdiction. For example, a prosthetic device called gutta percha is basically coagulated tree sap extracted from certain tropical trees and used to fill root canal. 21 C.F.R. 872.3850.

In any event, to say that smokeless tobacco products are "merely" processed is like saying that penicillin is merely processed mold or a biscuit is merely processed wheat. In processing the tobacco plant, ingredients and flavorings are added, in carefully calibrated proportions. In addition, to facilitate the absorption of nicotine by the user, manufacturers control alkalinity through fermentation or the addition of buffering agents, such as sodium carbonate or ammonium carbonate. 61 Fed. Reg. 45110-15. The processed tobacco is then packaged in different ways, in teabag-like pouches, for example, to further control the delivery of nicotine to the body. Id. 45115. The final product is no more a "mere" plant than the cancer drug Taxol, which is processed from tree bark.

The FDA's assertion of jurisdiction over tobacco products is based in part on the industry's extensive research and processing in order to control precisely the quantity and delivery of the pharmacologically-active nicotine. By the time smokeless tobacco products reach the consumer, they are far from plants. Given the manufacturers' well-documented control over the amount and form of nicotine in the processed product, the FDA has rightly determined that nicotine is intended by manufacturers "to affect the structure or any function" of the body. Accordingly, nicotine in smokeless tobacco products satisfies the FDCA definition of a drug.

B. Cigarettes And Smokeless Tobacco Products Are Nicotine-Delivery Systems.

Because nicotine is a drug within the meaning of the FDCA and tobacco products are intended to deliver that drug to the user, cigarettes and smokeless tobacco products precisely fit the definition of "combination products." 21 U.S.C. 353(g). The designation and treatment of combination products is not an ad hoc artifice created by the FDA for the purpose of regulating tobacco. Rather, the FDA's action is based on the FDCA and an agreement between the FDA's Center for Drug Evaluation and Research (CDER) and its Center for Devices and Radiological Health (CDRH), entered into in October 1991. Pursuant to that agreement, the FDA treats devices with the primary purpose of delivering or aiding in the delivery of a drug and which are distributed containing a drug (a "pre-filled drug-delivery system," such as a pre-filled syringe), as combination products, which may be regulated under either the drug or the device regulations. 61 Fed. Reg. 44402-03.

The delivery of a drug to the body through the means used by cigarettes or smokeless tobacco products is not unique. Cigarettes deliver the drug nicotine to the body through inhalation into the lungs, much like other combination products such as nebulizers. In addition, certain cigarettes have been specifically marketed for drug delivery. For example, Asthmador cigarettes were sold as an asthma treatment in the United States as recently as the 1970s. In France, Cigarettes Schulze Bengalias today uses the cigarette form to treat respiratory systems disorders by delivering to the body drugs such as those in stramonium leaf and digitalis leaf. See also 354 Bulk Cartons, 178 F. Supp. 847 (cigarette marketed for weight reduction); Fairfax Cigarettes, 113 F. Supp. 336 (cigarette marketed to prevent respiratory and other disease).

Smokeless tobacco products deliver nicotine to the body through absorption into the buccal pouch, the inner lining of the cheek. This means of delivery is particularly effective because a drug can directly enter the bloodstream from the buccal pouch, in contrast to the slower passage of a pill through the stomach. Other products that deliver drugs to the body through the membranes lining the mouth, without being swallowed, include various nitrates used to treat chest pain, such as angina; Fentanyl Oralet, a lollipop which delivers an anesthetic by initial rapid absorption through the mouth, as well as slower delivery through the gastrointestinal tract; asper-gum; and nicotine gum.

Nonetheless, plaintiffs argue that the FDA may not regulate tobacco products under the device regulations because the products achieve their effect through "chemical action," and the definition of devices excludes items that "achieve [their] primary intended purposes through chemical action." Second Brief 27-28; US Tob. Brief 15. See 21 U.S.C. 321(h). Under the FDCA, however, combination products necessarily have both drug components, which affect the body through chemical action, and device components, which do not. 21 U.S.C. 353(g). Frequently, the device components of the combination product "do not in themselves have any effect on a structure or function of the body." Second Brief 27. A syringe, for example, does not affect the body; only the drug injected through that device does so.

Moreover, although the statute specifies that for combination products that act primarily as drugs (such as tobacco products), "the persons charged with premarket review of drugs shall have primary jurisdiction," the FDCA says nothing about which regulations the FDA must apply to those products. 21 U.S.C. 353(g). That issue is addressed only by the agreement between CDER and CDRH, supra p. 23, which allows the FDA to regulate a pre-filled drug-delivery system under either the drug or the device regulations, no matter what the product's primary mode of action. 61 Fed. Reg. 44400-01. Although plaintiffs would require the FDA to regulate such products as drugs, they offer no cogent reason for imposing this requirement on the FDA. Neither the statute, the regulations, nor FDA precedent requires such a restriction. (See Footnote 6)

Plaintiffs further complain that tobacco products are not combination products because the device components could not be regulated apart from the drug nicotine. Second Brief 29. That argument seeks to impose a requirement beyond that established by the clear language of the statute, 21 U.S.C. 353(g), which plainly permits the FDA to regulate products like nebulizers and transdermal patches. See Second Brief 29 (conceding that nicotine patch is regulable as combination product). A nebulizer and a transdermal patch, without their drug components, are basically a canister and a sticker. Like a cigarette or chewing tobacco, the canister and the sticker are intended to deliver a drug to the product's user. Thus, for regulatory purposes under the FDCA, each is a drug-delivery system. See also 61 Fed. Reg. 44866 (Philip Morris report places tobacco products in same category of "nicotine delivery devices" as patches). And, like cigarettes and smokeless tobacco products after their use, when the drug has been extracted, the device becomes worthless.

C. Conclusion

Arguing that the FDA is trying to place "a square peg in a round hole," Second Brief 2, plaintiffs propound a constricted reading of the FDCA and applicable regulations. The FDCA, however, is not the tax code. Rather, in crafting the broad definitions which form the basis of the FDA's authority, Congress left to the FDA's expertise the decisions about which specific products are covered by the Act. Exercising its expertise, the FDA regulates numerous products that might not comport with a lay understanding of a drug or a medical device. See, e.g., 21 C.F.R. 878.4635 (tanning booth), 880.6050 (ice bag), 880.6265 (examination gown), 886.5842 (eyeglass frames), 886.5850 (non-prescription sunglasses). Nonetheless, unless expressly excluded from the FDCA definitions of drugs or devices, any product that meets one of those definitions falls within the FDA's jurisdiction. Therefore, the Court should sustain the FDA's determination that nicotine-containing tobacco products are subject to its regulatory authority.

III. THE FDA'S REGULATIONS PASS MUSTER UNDER THE FIRST AMENDMENT.

Amici recognize that commercial speech is entitled to substantial protection under the First Amendment. (See Footnote 7) It is by now a truism that for the average American the "concern for the free flow of commercial speech often may be far keener than his concern for urgent political dialogue." Bates v. State Bar of Arizona, 433 U.S. 350, 364, 97 S.Ct. 2691, 53 L.Ed.2d 810 (1977); see also City of Cincinnati v. Discovery Network, Inc., __ U.S. __, 113 S.Ct. 1505, 1512 & n.17, 123 L.Ed.2d 99 (1993). Our free market system depends on the unimpeded flow of information regarding the price and availability of goods and services to the consuming public. Id.

But there are also dangers in a free-for-all marketplace, and, at times, vigilant government action is needed to protect vulnerable segments of the public from false, deceptive, or overbearing sales campaigns. See, e.g., Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447, 98 S.Ct. 1925, 56 L.Ed.2d 444 (1978). The stream of commercial speech must flow "cleanly as well as freely." Edenfield v. Fane, 113 S.Ct. at 1799. This concern takes on special force where, as here, a powerful seller--the tobacco industry--has used its resources to saturate the marketplace to promote dangerous products to impressionable minors. Contrary to the industry's hyperbolic claims, the FDA's regulations do not violate the First Amendment for two interrelated reasons.

First, it is impossible to imagine a more compelling governmental interest than protecting children from being enticed into experimenting with addictive and often deadly tobacco products. As the Supreme Court has repeatedly emphasized, protecting children is "an extremely important justification" for imposing restraints on potentially harmful speech. E.g., Denver Area Educ. Telecommunications Consortium v. FCC, __ U.S. __, 116 S.Ct. 2374, 2392, 135 L.Ed.2d 888 (1996) (plurality opinion); Anheuser-Busch, Inc. v. Schmoke, No. 94-1431, slip op. at 7-8 (4th Cir. Nov. 13, 1996) ("Anheuser-Busch II"). One can search the industry's brief in vain for any discussion of the strength of the interests advanced by the FDA's rules. But the overriding importance of those interests is the industry's Achilles' heel. As even the industry concedes, the First Amendment demands a balancing test in commercial speech cases, and the governmental interests here overshadow the minimal intrusion on the industry's First Amendment rights.

Second, the FDA has calibrated its rules as carefully as possible to interdict only selling messages aimed at minors, who may not lawfully purchase tobacco products. Nothing in the FDA's rules deprives the industry of its right to say whatever it wants; all the FDA has regulated are the means by which the industry may convey its selling messages to ensure that they are not directed to children. Only those advertisements certain to be seen by substantial numbers of kids are regulated, leaving ample channels open for industry to communicate with adults. While the industry quibbles with the FDA's line-drawing, it cannot attack the FDA's premise that the industry has no constitutional right to advertise tobacco products directly to minors. Because the FDA has fine-tuned its advertising rules to that end, the rules withstand constitutional challenge.

A. The First Amendment Does Not Bar The FDA From Regulating Tobacco Advertising Directed At Minors.

Since 1980, the Supreme Court has employed the four-part Central Hudson test in assessing restraints on commercial speech. Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557, 563-64, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980). Accord Florida Bar, 115 S.Ct. at 2376; Rubin, 115 S.Ct. at 1588. The test inquires, in relevant part:

  • first, whether the speech concerns an unlawful activity or is misleading;
  • second, whether the government's asserted interest in regulating the speech is substantial;
  • third, whether the restraint directly advances the government's interest;

  • fourth, whether the legislation is no more extensive than necessary to serve the government's interest.
Central Hudson, 447 U.S. at 566. In more recent cases, the Court has explained that "[t]he last two steps of the Central Hudson analysis basically involve a consideration of the 'fit' between the legislature's ends and the means chosen to accomplish those ends." Rubin, 115 S.Ct. at 1591 (citation omitted). The FDA's rules pass muster under each prong of this test. (See Footnote 8)

1. Tobacco Sales To Minors Are Unlawful. The first Central Hudson step is to consider whether the speech concerns lawful activity. Tobacco advertising aimed at minors fails this test. The heart of the FDA's regulation is a nationwide prohibition against the sale of tobacco products to minors that fortifies existing state prohibitions. Thus, the FDA's advertising rules regulate speech that, to a large degree, concerns an unlawful activity--promoting tobacco products to minors. Indeed, when the tobacco industry targets teenagers in its ads, it is, at the very least, encouraging the wholesale violation of law. (See Footnote 9)

For example, many of the industry's advertising campaigns--such as the "Joe Camel" campaign--were initiated to seduce kids into trying cigarettes. See 61 Fed. Reg. 44479-81; 60 Fed. Reg. 41330. The FDA has also assembled copious evidence that industry's advertising campaigns are tailored to induce minors to experiment with tobacco products. 60 Fed. Reg. 41330-31. And the FDA's evidence shows that industry's promotional campaigns have failed adequately to distinguish between minors and adults, frequently resulting in, for example, samples being given to teenagers. Id. 41337-38.

The Supreme Court has emphatically sustained efforts to forbid advertising that promotes unlawful activities. In Pittsburgh Press Co. v. Pittsburgh Comm'n on Human Relations, 413 U.S. 376, 93 S.Ct. 2553, 37 L.Ed.2d 669 (1973), the Court upheld a ban on advertising employment opportunities in sex-designated columns. For the Court, the dispositive fact was that discrimination based on sex in employment "is illegal activity." Id. at 388 (emphasis in original). And the Fourth Circuit's recent ruling in Anheuser-Busch II emphasized that Baltimore's restrictions on outdoor advertising of tobacco and alcohol products were justified because the consumption of those products by minors "has already [been] banned directly and forthrightly through legislation." Slip op. at 7. Just as in Pittsburgh Press and Anheuser-Busch II, the only advertising regulated by the FDA relates to an illegal transaction: the sale of tobacco products to minors.

The industry does not challenge the principle that speech proposing an illegality may be restrained. Instead, it argues that the FDA overreaches by restricting ads that "relate to" illegal conduct. But this argument distorts the FDA's rules, which do not simply target ads that "relate" in some amorphous way to an illegal act, but only regulate ads that actually propose an illegal transaction by enticing minors to obtain tobacco products. However much the industry would prefer otherwise, ads need not say "Children: Please Smoke Camels" to propose an illegal transaction.

The industry's own illustration exposes the hollowness of its position. The industry argues that many legal products, such as automobiles, firearms, and alcohol, are subject to unlawful use by minors and that the "fact that some 14-year-olds attempt to drive would mean that car advertisements are `related to' unlawful activity." Third Brief 10 n.13. But there is no evidence comparable to that amassed on tobacco that shows that manufacturers of other products have engaged in broad-scale, sustained campaigns to encourage minors to break the law. Surely the First Amendment would be no impediment to government prohibiting ads that enticed minors to "borrow" their parents' cars or ads that used Joe-Camel-like cartoon figures to coax kids into using hunting rifles or drinking vodka. Indeed, the Fourth Circuit's ruling in Anheuser-Busch II refutes industry's position here, since the Court upheld restraints on tobacco and alcohol ads precisely because they encouraged children to obtain products forbidden to them by law. Accordingly, because the "speech" restrained by the FDA's rules solicits an illegal act, it is entitled to no First Amendment protection.

2. The Governmental Interest Is Substantial. The next Central Hudson inquiry evaluates the governmental interests prompting the restriction. The FDA's rules serve at least two distinct, but interrelated, interests, each of which is compelling. First, the FDA's rules will prevent impressionable minors from being induced into experimentation with tobacco products--experimentation that often leads to life-long addiction and serious health problems, including premature death. 61 Fed. Reg. 44472; 60 Fed. Reg. 41354. Preventing the addiction of what the FDA estimates to be 250,000 youngsters each year is surely a governmental interest of the highest order. See, e.g., Anheuser-Busch II, slip op. at 7-8 ("[C]hildren deserve special solicitude in the First Amendment balance because they lack the ability to assess and analyze fully the information presented through commercial media").

Second, the FDA seeks to avoid the enormous cost, to both government and the private sector, of providing health care to future generations of smokers. The FDA estimates that the annual benefits of reduced tobacco-related disease mortality range from $24.6 to $39.7 billion. 60 Fed. Reg. 41359. Even that estimate understates the benefits of the rule, since it does not take into account "softer," non-quantifiable variables, such as the value to family members of preventing the death or disease of a loved one or a provider, or of avoiding the pain and suffering that smoking-induced illness often inflicts. This Court ought to be reluctant to interfere with a program that confers such dramatic benefits on society.

3. The FDA's Regulations Are Well-Tailored To The Agency's Stated Objectives. The final two prongs of the Central Hudson test--whether the restriction on commercial speech directly advances the governmental interest and whether the restriction is no more extensive than necessary to serve that interest--are analyzed together by asking whether there is a reasonable "fit" between the agency's objectives and the means selected by the agency to achieve them. See, e.g., Rubin, 115 S.Ct. at 1591; Florida Bar, 115 S.Ct. at 2380. The First Amendment demands "a fit that is not necessarily perfect, but reasonable; that represents not necessarily the single best disposition but one whose scope is in `proportion to the interest served,' In re R.M.J., [455 U.S. 191, 203]. * * * Within those bounds we leave it to the governmental decision makers to judge what manner of regulation may best be employed." Board of Trustees v. Fox, 492 U.S. 469, 475, 109 S.Ct. 3028, 106 L.Ed.2d 388 (1989). Accord United States v. Edge Broadcasting Co., __ U.S. __, 113 S.Ct. 2696, 2707, 125 L.Ed.2d 345 (1993).

In Edenfield v. Fane, the Court explained that the "penultimate prong of the Central Hudson test requires that a regulation impinging upon commercial expression `directly advance the state interest involved; the regulation may not be sustained if it provides only ineffective or remote support for the government's purpose.'" 113 S.Ct. at 1800 (quoting Central Hudson, 447 U.S. at 564). The government's burden, the Court has noted, "is not satisfied by mere speculation or conjecture;" rather, the government "must demonstrate that the harms it recites are real and that its restrictions will in fact alleviate them to a material degree." Rubin, 115 S.Ct. at 1592 (quoting Edenfield, 113 S.Ct. at 1800). Not surprisingly, the industry has made no serious effort to contest that the "harms" the FDA "recites are real." Indeed, the FDA's findings that tobacco use by minors has reached epidemic proportions and that the inevitable health consequences will exact an appalling toll on society are not disputed.

Similarly, for at least three reasons, the FDA surmounts the hurdle of showing that its proposals will alleviate "to a material degree" the problem of children turning to tobacco products. First, the FDA has compiled substantial evidence showing the direct correlation between colorful, image-laden ads and underage smoking, 61 Fed. Reg. 44466-68, 44475-88, and studies in the record show that advertising has a profound influence on a minor's decision to experiment with tobacco. Id. 44466-68; 60 Fed. Reg. 41329-24. Additional studies confirm that each of the advertising and promotional techniques addressed by the FDA, such as outdoor advertising and promotional give-aways, has a direct and substantial impact on minors. Id. This evidence--which establishes that the FDA's rules will dramatically lessen tobacco use by minors--surely meets the Edenfield standard. Indeed, Kentucky, North Carolina and Virginia concur in the FDA's assessment. They condemn the FDA rule because it will result in revenue losses occasioned by a decline in tobacco use. KY Brief 2-3; NC Brief 1 n.1; VA Brief 3-4. (See Footnote 10)

Second, the Court has long understood the close connection between advertising and the stimulation of demand, taking it as an article of faith that restraints on advertising will diminish demand. Edge Broadcasting, 113 S.Ct. at 2707; Central Hudson, 447 U.S. at 569. As the Court has often noted, sellers like tobacco companies would not invest enormous sums in advertising unless they expected a pay-off in terms of increased demand. Id.

Third, contrary to the industry's claim, the quantum of evidence required on this point is not high. To be sure, Rubin and Edenfield suggest that the government bears the burden of showing that the